SAFETY DATA SHEET Page 1 of 6 Product Name: Eclipse E Injection Reviewed on: 7 April 2014

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1 Page 1 of 6 Product Name: Eclipse E Injection Reviewed on: 7 April 2014 SECTION 1: IDENTIFICATION OF THE SUBSTANCE AND SUPPLIER Product name: Product code: Recommended use: Company details: Eclipse E Injection A10640 For the control and treatment of parasites in cattle. Merial Ancare Address: Level 3, Merial Building Osterley Way Manukau City New Zealand Telephone number: Phone: Fax: Emergency telephone number: Date of preparation: March 2011 Merial Ancare Freephone: National Poisons Centre : (0800 POISON) Fire Service, Ambulance : Dial 111 SECTION 2: COMPOSITION/INFORMATION ON INGREDIENTS Chemical characterization: Product components: Name CAS Proportion Eprinomectin Levamisole phosphate BHT Dimethylacetamide Hazard classifications: SECTION 3: HAZARDS IDENTIFICATION 6.1D Acute oral toxin 6.5B Contact sensitiser 6.6B Mutagen 6.8A Reproductive/developmental toxin 6.8C Reproductive/developmental toxin via lactation 6.9A Target organ toxin 9.1A Aquatic toxin 9.2C Soil toxin 9.3B Vertebrate toxin 9.4A Invertebrate toxin Priority and secondary identifiers: Risk and safety phrases: Warning KEEP OUT OF REACH OF CHILDREN Warning Dangerous to the environment 6.1D May be harmful if swallowed. 6.5B Repeated exposure may cause skin allergy. 6.6B Levamisole may possibly cause damage to genetic material. 6.8A Eprinomectin and Dimethylacetamide can affect development and/or reproduction. 6.8C BHT may possibly have effects on or via lactation. 6.9A Levamisole (blood and haematopoietic system) may possibly cause organ damage. Wash hands and exposed skin before meals and after use. Avoid skin contact. Handle with care. 9.1A Very toxic to aquatic organisms. 9.2C Harmful to the soil environment. 9.3B Toxic to terrestrial vertebrates. 9.4 A Very toxic to terrestrial invertebrates. Avoid contamination of any water supply with product or empty

2 Page 2 of 6 container. Avoid release to the environment. Necessary first aid measures: Workplace facilities: Required instructions: SECTION 4: FIRST AID MEASURES For advice contact the National Poisons Centre on 0800 POISON ( ), or a doctor immediately. INGESTION: If swallowed seek medical attention. Do NOT induce vomiting. EYES: If splashed in eyes wash out immediately with water. SKIN: If skin or hair contact occurs remove contaminated clothing and flush skin and hair with running water. INHALATION: Remove to fresh air. SELF-INJECTION: Seek medical attention. No special facilities required. Observe good work practices and avoid skin and eye contact. Wash hands and exposed skin before meals and after use. Do not eat or drink while using. Launder protective clothing separately from other clothing, and before each reuse. Notes for medical personnel: Apply symptomatic therapy (no specific antidote). Note the nature of the product (possible mutagen, reproductive/developmental toxin, sensitiser and irritant). Type of hazard: SECTION 5: FIRE FIGHTING MEASURES Non flammable, Non combustible, Non explosive Fire hazard properties: Regulatory requirements: Extinguishing media and methods: Hazchem code: Recommended protective clothing: Eprinomectin-Levamisole Injection is not classified as flammable, and will not support combustion. Hazardous fumes when heated to decomposition. Not applicable Treat the fire as for the other materials present. Do not allow water to enter drains. 2X When fighting a major fire wear full protective clothing including breathing apparatus Emergency procedures: SECTION 6: ACCIDENTAL RELEASE MEASURES Wear suitable protective clothing. Restrict access to contaminated area. Contain the spill and prevent further dispersion. Retrieve intact containers from site. Place damaged containers into containment devices. Absorb spills with inert material and place in waste containers. Wash the area with water and absorb with further inert material. Collect spilled material and place in sealable containers for subsequent disposal. Prevent contamination of water courses or sewers. Dispose of waste safely.

3 Page 3 of 6 SECTION 7: HANDLING AND STORAGE Precautions for safe handling: Apply with well-maintained and calibrated equipment. Handle with care Regulatory requirements: Approved handlers: Conditions for safe storage: Store site requirements: Not required Store at 2-8 C. Protect from light. Keep out of reach of children. This substance is subject to a requirement for an emergency management plan, secondary containment and signage, whenever it is held in quantities of 100L or more. See Hazardous Substances (Emergency management) regulations 25 to 42. Packaging: Packaging Schedule 3 (UN Packing Group III) for quantities >1L (Hazardous Substances Packaging Regulations 2001). Workplace exposure standards: SECTION 8: EXPOSURE CONTROL/PERSONAL PROTECTION 2,6-Di-tert-butyl-p-cresol: TWA 10mg/m 3 Dimethylacetamide: TWA 10ppm (36mg/m 3 ) Application in the workplace: Exposure standards outside the workplace: Engineering controls: Personal protection: References: Prevent exposure by using engineering controls, personal protective equipment and work practices that prevent skin and eye contact. TELs and EELs are not set at this time. Use only in well ventilated areas. Clothing should consist of overalls with long sleeves, and impervious gloves. Wear eye protection (eg. glasses, goggles or face shield). Specify product data: Required specifications: Further specifications: Specific advice: SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES Formulation type: Solution Appearance: Clear solution Specific gravity: g/ml Vapour Pressure: NA Solubility in Water: Eprinomectin is insoluble in water

4 Page 4 of 6 Stability of the substance: Conditions to avoid: Material to avoid: Hazardous decomposition products: Hazardous polymerization: Specific data: SECTION 10: STABILITY AND REACTIVITY Stable under normal conditions of use and storage. No specific conditions to avoid No specific materials to avoid. No hazardous decomposition products are expected, except when heated to decomposition. Components are not expected to form hazardous polymers. Data and interpretation: SECTION 11: TOXICOLOGICAL INFORMATION Eclipse E Injection May be harmful if swallowed. Repeated exposure may cause skin allergy. Levamisole may possibly cause damage to genetic material. Eprinomectin and Dimethylacetamide can affect development and/or reproduction. BHT may possibly have effects on or via lactation. Levamisole (blood and haematopoietic system) may possibly cause organ damage. Summaries data: INGREDIENTS Eprinomectin Rat (F) LD50 55 mg/kg bw Ref. [EMEA Summary report 1, 1996] 2-generation repro study with 1 litter for the first generation and 2 litters for the second generation was performed in rats, doses of 1, and 6 mg/kw bw/day. Maternal toxicity characterised by a diminution of the mating/ reproductive performance was observed at the highest level especially in adult F1. An increase in pup mortality, a marked reduction in pup growth and body tremors among all pups were noted at the highest level. Treatment related body termors were also noted at mg/kg bw/day in 4 out of 26 litters of the F2 generations. 1 mg/kg was retained as the NOEL for growth and reproductive performance of the rat. [EMEA Summary report 1, 1996] Target organ toxicity EndPoint: LOAEL Primary Organ: Neurotoxicity (nervous system) 53 week oral toxicity study in dogs, doses of , 1 and 2 mg/kg bw/day. At the highest level mydriasis (pupil dilation) was reported. Histopathological examination showed a slight focal degeneration in the pons area and/or the cerebellar nuclei in 3/8 dogs. This degenerative change was characterised by neuronal enlargement that resulted from increased eosinophilic vacuolated cytoplasm with nuclear displacement. Although this change affected 1-3 neurons per dog it was attributed to treatment because other compounds in this class have caused neuronal degeneration in dogs in this area of the brain. NOEL = 1 mg/kg bw/day. [EMEA Summary report 1, 1996] Levamisole Levamisole is a broad-spectrum anthelmintic with a long history of use in cattle and sheep. It has moderate to high acute toxicity [LD50 (oral, rats & mice) = mg/kg]. A potential mutagen [levamisole] induced chromosome gaps and breaks in human lymphocytes in vitro and in vivo and levamisole hydrochloride induced an increase in the mitotic index, numerical chromosomal

5 Page 5 of 6 changes (aneuploidy, polyploidy) and structural chromosomal changes]. Haemolytic anaemic was the main toxic effect demonstrated in repeated dose animal studies (LOAEL 1.25mg/kg/day). In humans, levamisole has been associated with various non-specific effects (nausea, vomiting, rashes). Levamisole has induced leucopenia and agranulocytosis (idiosyncratic) at low doses. BHT Maternal LOAEL = 200 mg/kg bw/day in Wistar rats. No LOAEL could be determined for the F1 generation (IUCLID, 2000). In a range finding study in designed to assess the tolerance of rats to BHT, the body weight of F1 pups from BHT-treated dams at weaning were less than those from the control groups. In the main experiment, pups from BHT treated dams were found to lose weight during the lactation period (DART). In a further study, pups from dams treated with BHT were reported to show stunted growth, with poor fur condition and were less active. Dimethylacetamide Known or presumed human reproductive or developmental toxicants. SECTION 12: ENVIRONMENTAL INFORMATION Eclipse E Injection Very toxic to aquatic organisms. Harmful to the soil environment. Toxic to terrestrial vertebrates. Very toxic to terrestrial invertebrates. INGREDIENTS Eprinomectin Ecotoxicity to: Crustacean: Daphia EC ug/l (= mg/l) Ref. NRA report Australia Dec 1997; Bioaccumulative: Yes; Rapidly Degradable: No Algae Lemna minor, 168 hr EC mg/l Ref. [ Bioccumulative: Yes; Rapidly Degradable: No Soil DT 50 > 30 days: yes Terrestrial vertebrates: Mallard duck LD50 24 mg/kg Ref. [NRA report Australia Dec 1997] Terrestrial invertebrates: Bee LD50 (contact) ug/bee; Ref. [Evaluation on Abamectin. July DEFRA, Pesticides Safety Directorate, UK] Levamisole Levamisole is potentially toxic to terrestrial vertebrates based on laboratory animal toxicity data [LD 50 (oral, rats & mice) = mg/kg]. Not toxic to fish or honey bees. Levamisole does not bioaccumulate in biological systems. In soil, levamisole has a half-life of five to seventy five days depending on sunlight, soil type and climatic conditions. Levamisole binds strongly to soil particles and organic matter. It does not leach in soils and is readily degraded by hydrolysis and microbial action.

6 Page 6 of 6 Disposal information : SECTION 13: DISPOSAL CONSIDERATIONS Preferably dispose of the product by use. Otherwise dispose of product and packaging at an approved landfill or other approved facility. Avoid contamination of any water source. Burn empty container in an appropriate incinerator, if circumstances such as wind direction permit. Otherwise crush or puncture and bury in a suitable landfill. Do NOT use container for any other purpose. Relevant information: SECTION 14: TRANSPORT INFORMATION Dangerous Goods for transport. ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S. (Eprinomectin 0.7%) UN Number: 3082 Dangerous Goods Class: 9 The maximum quantity per package of this substance allowed for carriage on public transport is 1L. Other requirements: Regulatory status: SECTION 15: REGULATORY INFORMATION Registered pursuant to the ACVM Act 1997, No. A10640 See for registration conditions Approved pursuant to the HSNO Act, Approval Code HSR See for approval conditions SDS is required for quantities greater than or equal to 0.1L HSNO and ACVM controls: Refer to Section 3 List exposure limits: Additional information: SECTION 16: OTHER INFORMATION For product information visit the Merial website While the information set forth is believed to be accurate as of the date hereof, MERIAL NZ LTD. makes no warranty with respect hereto and disclaims all liability from reliance thereon.

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